NCT01308736

Varenicline-Aided Cigarette Reduction in Smokers Not Ready to Quit

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

The investigators will randomize smokers to receive 1) Varenicline + smoking cessation/reduction counseling or 2) Placebo pill + smoking cessation/reduction counseling. Neither the participants nor the research therapists/evaluators will know to which condition (active or placebo pill) the participants have been assigned i.e., a double-blind study). The medication and weekly counseling will occur for 28 days. Participants will complete assessment measures just before the start of treatment (baseline), at the end-of-treatment, at 1-month, 3-month, and at 6-months to determine if there are differences in tobacco use between treatment groups.

Conditions

• Tobacco Use Disorder

Interventions

Type	Name	Description
DRUG	Varenicline	Participants randomized to receive varenicline will follow the Pfizer recommended dosing schedule (0.5 mg QD on days 1-3, 0.5 mg BID on days 4-7, and 1 mg BID thereafter.
DRUG	Placebo pill	Participants randomized to receive placebo pill will follow the same dosing schedule as those randomized to receive varenicline (1 pill labelled 0.5 mg on days 1-3, pills labelled 0.5 mg BID on days 4-7, and pills labelled 1 mg BID thereafter.

Timeline

• Start date: 2011-01-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2011-03-04
• Last updated: 2017-07-17
• Results posted: 2015-07-23

Locations

1 site across 1 country: United States